A study to see the safety of Fixed Dose Combination (FDC) of Sofosbuvir/Daclatasvir

Phase 4

Not yet recruiting

• Conditions: Chronic viral hepatitis C,

• Registration Number: CTRI/2019/12/022216
• Lead Sponsor: Mylan Laboratories Limited

Brief Summary

This is a phase-IV multicenter, prospective, open label single arm study designed to determine the safety & efficacy of Sofosbuvir/Daclatasvir fixed dose combination in adult Indian patients with confirmed chronic HCV genotype 3 infection.

The Primary objective of the study - To assess the safety and tolerabilitThis is a phase-IV multicenter, prospective, open label single arm study designed to determine the safety & efficacy of Sofosbuvir/Daclatasvir fixed dose combination in adult Indian patients with confirmed chronic HCV genotype 3 infection. The Primary objective of the study - To assess the safety and tolerability of Sofosbuvir/Daclatasvir FDC in adults with Chronic HCV genotype 3 infection.

The Secondary objective of the study - To determine the efficacy of fixed dose combination (FDC) of Sofosbuvir/Daclatasvir in adults with Chronic HCV Genotype 3 infection, as measured by the sustained virologic response rates at 12 weeks (SVR12) after End of Treatmenty of Sofosbuvir/Daclatasvir FDC in adults with Chronic HCV genotype 3 infection.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-12
• Last Update Posted: 2020-09-12

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• Willing and able to provide written informed consent 2.
• Male or female, age equal to or greater than 18 to equal to or less than 65 years 3.
• Confirmed chronic HCV genotype 3 infection 4.
• Eligible to receive sofosbuvir/ daclatasvir fixed dose combination in HCV genotype 3.

Exclusion Criteria

• Pregnant or nursing female or male with pregnant female partner not willing to use adequate physical barrier.
• Chronic liver disease of a non-HCV etiology 3.
• Known coinfection with hepatitis B virus (HBV) and/or human immunodeficiency virus (HIV) 4.
• Documented or suspected Hepatocellular Carcinoma (HCC) 5.
• Evidence of liver cirrhosis 6.
• Patients with adequate hemoglobin levels 7.
• Patients with impaired renal function 8.
• Patients on Medicinal products which are contraindicated to be used with sofosbuvir/ daclatasvir based combination therapy 9.
• History of significant pulmonary disease, significant cardiac disease or porphyria.

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events	Treatment period and up to 4 weeks after EOT

Secondary Outcome Measures

Name	Time	Method
1. Percentage of subjects having the Sustained Virological Response i.e. virological response measured at SVR12 Visit	12 weeks after the End of Treatment

Trial Locations

Locations (21)

Aman Hospital and Research Centre; 🇮🇳 Vadodara, GUJARAT, India

Amar Hospital; 🇮🇳 Patiala, PUNJAB, India

Dayanand Medical College & Hospital; 🇮🇳 Ludhiana, PUNJAB, India

G. B. Pant Hospital; 🇮🇳 Delhi, DELHI, India

Gleneagles Global Hospitals; 🇮🇳 Hyderabad, TELANGANA, India

Guntur Medical college & Govt. General Hospital; 🇮🇳 Guntur, ANDHRA PRADESH, India

Indira Gandhi Institute of Medical Sciences; 🇮🇳 Patna, BIHAR, India

Kanoria Hospital and Research Centre; 🇮🇳 Gandhinagar, GUJARAT, India

KRM Hospital and Research Centre; 🇮🇳 Lucknow, UTTAR PRADESH, India

M. V. Hospital & Research Centre; 🇮🇳 Lucknow, UTTAR PRADESH, India

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Aman Hospital and Research Centre

🇮🇳Vadodara, GUJARAT, India

Dr Dhaval Janardanbhai Dave

Principal investigator

7984051650

dhawal07dave@gmail.com